US11559394B2ActiveUtilityA1

Prosthetic valves, valve leaflets and related methods

89
Assignee: BOSTON SCIENT SCIMED INCPriority: May 19, 2016Filed: Jul 30, 2019Granted: Jan 24, 2023
Est. expiryMay 19, 2036(~9.9 yrs left)· nominal 20-yr term from priority
D04H 1/5412C08K 2003/2227A61F 2250/0036A61F 2250/0023A61F 2/2412A61F 2250/0076D01F 8/00A61F 2210/0076C08K 3/22A61L 27/306C08K 2003/2255A61F 2250/0017A61F 2/2418A61L 27/14C08K 2003/2241A61F 2/2415B32B 27/02A61F 2250/0028D04H 3/147
89
PatentIndex Score
3
Cited by
347
References
19
Claims

Abstract

Examples herein include prosthetic valves, valve leaflets and related methods. In an example, a prosthetic valve is included having a plurality of leaflets. The leaflets can each have a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion. The leaflets can include a fibrous matrix including polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. A coating can surround the polymeric fibers within the fibrous matrix. The coating can have a thickness of about 3 to about 30 nanometers. The coating can be formed of a material selected from the group consisting of a metal oxide, a nitride, a carbide, a sulfide, or fluoride. In an example, a method of making a valve is included. Other examples are also included herein.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A prosthetic valve comprising:
 a plurality of leaflets, 
 the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets, 
 the leaflets comprising a fibrous matrix, the fibrous matrix comprising polymeric fibers; 
 a coating surrounding individual polymeric fibers within the fibrous matrix, the coating comprising a first layer and a second layer, 
 wherein one layer of the first layer and the second layer comprises a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide, and the other layer of the first layer and the second layer comprises a polymer. 
 
     
     
       2. The prosthetic valve of  claim 1 , wherein the one layer comprises a metal oxide. 
     
     
       3. The prosthetic valve of  claim 2 , the metal oxide comprising aluminum oxide (Al 2 O 3 ). 
     
     
       4. The prosthetic valve of  claim 1 , wherein a density of the fibrous matrix is symmetric across a thickness of at least one of the plurality of leaflets. 
     
     
       5. The prosthetic valve of  claim 1 , wherein a density of the fibrous matrix is asymmetric across a thickness of at least one of the leaflets. 
     
     
       6. The prosthetic valve of  claim 1 , each leaflet having an upstream side and a downstream side, wherein a density of the fibrous matrix is greater on the upstream side of each leaflet than on the downstream side of each leaflet. 
     
     
       7. The prosthetic valve of  claim 1 , wherein a flexural stiffness of at least one of the leaflets is less than 8 g/cm. 
     
     
       8. The prosthetic valve of  claim 1 , the fibrous matrix comprising polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. 
     
     
       9. The prosthetic valve of  claim 1 , further comprising a frame, wherein the leaflets are attached to the frame. 
     
     
       10. A prosthetic valve comprising:
 a plurality of leaflets, 
 the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets, 
 each leaflet among the plurality of leaflets comprising a fibrous matrix, the fibrous matrix comprising polymeric fibers; and 
 a coating surrounding individual polymeric fibers within the fibrous matrix, wherein the coating comprises a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide; 
 wherein a flexural stiffness of the leaflets is less than 8 g/cm. 
 
     
     
       11. The prosthetic valve of  claim 10 , the coating comprising a metal oxide, the metal oxide comprising aluminum oxide (Al 2 O 3 ). 
     
     
       12. The prosthetic valve of  claim 10 , wherein a density of the fibrous matrix is asymmetric across a thickness of the leaflets. 
     
     
       13. The prosthetic valve of  claim 10 , each leaflet having an upstream side and a downstream side, wherein a density of the fibrous matrix is greater on the upstream side of each leaflet than on the downstream side of each leaflet. 
     
     
       14. The prosthetic valve of  claim 10 , the fibrous matrix comprising polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. 
     
     
       15. The prosthetic valve of  claim 10 , further comprising a frame, wherein the leaflets are attached to the frame. 
     
     
       16. A prosthetic valve comprising:
 a plurality of leaflets, 
 the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets, 
 the leaflets comprising a first zone and a second zone across a thickness thereof, 
 the first zone comprising a first fibrous matrix, the first fibrous matrix comprising polymeric fibers; 
 the second zone comprising a second fibrous matrix, the second fibrous matrix comprising polymeric fibers; 
 a coating surrounding individual polymeric fibers within the first fibrous matrix, the coating comprising a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide. 
 
     
     
       17. The prosthetic valve of  claim 16 , the first zone having a different fiber density than the second zone. 
     
     
       18. The prosthetic valve of  claim 16 , wherein the first zone and the second zone have a combined thickness of 0.002″ to 0.02″. 
     
     
       19. The prosthetic valve of  claim 16 , the polymeric fibers of the first fibrous matrix comprising a polymer selected from the group consisting of poly(ethylene oxide), polyethylene, polyisobutylene polyurethane (PIBU), poly(styrene-block-isobutylene-block-styrene (SIBS), polypropylene, polystyrene, polyvinylchloride, polyisobutylene (PIB), poly(styrene) polyurethanes, polyvinylidene difluoride, poly(methyl methacrylate), polyethylene glycol, polyanilines, polypyrroles, polythiophenes, polyphenols, polyacetylenes, polyphenylenes, polyacrylonitriles, polylactic acids, polycaprolactone, polyglycolides, polyvinyl acetates, cellulose acetate, chitosan, proteins, carbohydrates and copolymers including one or more of these.

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